Roche Diagnostics Corporation: Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.

Recall number

Z-2389-2018

Recalling firm

Roche Diagnostics Corporation

Product

Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.

Status

Terminated

Initiated

2018-04-27

Posted

not on file

Terminated

2020-05-11

Reason

The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.

Root cause

Under Investigation by firm

Action

On April 27, 2018, the firm issued an Urgent Medical Device Correction letter to all affected customers. The letter advised customers in the following workaround to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay. The firm stated these steps are to be carried out temporarily until further information is provided: 1. Perform a thorough inspection of your pre-analytical handling to ensure a correct assay performance of Elecsys Vitamin D total II and to comply with the individual specifications of the primary tube manufacturers for all tubes in use (centrifugation conditions are particularly important as well as the elimination of foam/bubbles from the surface of the sample). 2. If the issue persists, switch from plasma to serum. 3. If you still encounter the issue for plasma or serum, re-centrifuge the sample in a secondary tube for 10 minutes at 2000 x g prior to measurement with the Elecsys Vitamin D total II assay. If you are still experiencing issues after completing the steps above, discontinue the use of the Elecsys Vitamin D Total II assay. Contact the Roche Support Network Customer Support Center at 1-800-428-2336. For the MODULAR ANALYTICS E 170 module, cobas e 411 analyzer, and cobas e 601 and 602 analyzers, the availability of the Elecsys Vitamin D Assay (catalog number 06506780160) has been extended and may be used as an alternate method until this issue is resolved. Customers were asked to do the following: " Follow the workaround outlined in this Urgent Medical Device Correction (UMDC) to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay until further information is provided. " If none of the workaround actions listed on the previous page successfully resolve the issue, please discontinue use of the Elecsys Vitamin D total II assay and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " For all analyzers except the cobas e 801 module, the V

Quantity

347 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

No specific lot codes. This issue affects users of the cobas e 801 module.

510(k) numbers

["K162840"]

PMA numbers

not on file

Product code

MRG

Firm FEI

1823260

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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